Marc J. Scheineson

Marc is an FDA and congressional insider experienced in strategically resolving regulatory and legislative issues for product manufacturers using the legal levers available in Washington, D.C.

Successfully represented a major pharmaceutical manufacturer in amending an analgesic over-the-counter drug monograph to recognize preventative cardiovascular uses of aspirin.

Assisted in the preparation and advocacy of a successful orphan drug designation request for a biologic leukemia drug.

Obtained an FDA Division of Drug, Marketing, and Advertising (DDMAC) warning letter against the illegal marketing practices of the competitor manufacturer of the Cox-2 inhibitor.

Successfully defended against a DDMAC investigation of the marketing practices of an MRI-MRA imaging contrast agent maker.

Participated on company review committees for the launch and dissemination of promotional materials for a biologic arthritis drug, and for collagen device dermal filler products.

Performed regulatory due diligence for the acquisition of companies and products, including over-the-counter cough medicine, high dose expectorant, infant formulas, multiple prescriptions and over-the-counter drug products, and heart monitoring devices.

Led a legal and regulatory team to obtain the first FDA clearance of private label infant formula.

Negotiated an FDA Good Manufacturing Practice consent decree for a catheter maker that preserved existing inventory.

Assisted with the New Drug Application approval of the first levothyroxine product, and removed unapproved guaifenesin products.

Represented a major national clinical research organization in FDA self-disclosure, inspection and negotiations for remedial action.

Led a litigation and regulatory team to preserve marketing rights for “grandfathered drug” products until FDA approvals could be obtained.

Assisted in the review, revision and acquisitions by a major online medical information provider of an accredited continuing medical education sponsor.

Mr. Scheineson is a partner in the Washington, D.C., office, where he heads the firm’s Food and Drug Law Practice. He advises companies on a wide range of issues, including product approvals, marketing, clinical studies and enforcement. Previously, he served as the associate commissioner for legislative affairs of the Food and Drug Administration. He was involved there in many agency innovations, including prescription drug user fees, debarment, medical device amendments and nutritional labeling. He was also counsel to the ranking member of the Health Subcommittee of the House of Representatives Committee on Ways and Means, and a senior vice president of Ketchum Communications. Mr. Scheineson is also experienced with the application of the OIG anti-kickback statute, HIPAA privacy rules, patent term exclusivity, institutional review board regulation, human research protection, scientific misconduct, technology transfer and licensing, advertising and promotion law, ACCME accreditation, and advises on the FDA regulatory aspects of corporate acquisitions. Mr. Scheineson received an LL.M. degree from the Georgetown University Law Center, and his B.A. and J.D. degrees from the University of Cincinnati and its College of Law.